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Completed

NCT Number: NCT05691686

Bread Structure and Postprandial Metabolic Responses

The structural properties of bread are considered one of the most important factors that can affect its digestibility, glucose homeostasis and postprandial metabolic responses. The purpose of this study is to examine the effects of consumption of less processed whole grain bread products (wheat and fortified with legumes) in comparison with finely milled whole grain bread products on postprandial glycaemic response and appetite regulation.

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Key information

Conditions

Postprandial Hyperglycemia Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amalia Yanni

Athens, Attica, 17671, Greece

About this study

Postprandial glucose response caused by bread products of different degree of processing, as well as their appetite regulating properties will be evaluated. In the intervention there are totally four samples, the reference (white wheat bread), the less processed whole wheat bread, the whole wheat bread fortified with finely milled legumes (chickpeas), the whole wheat bread fortified with less processed legumes (chickpeas). The volunteers that will be enrolled in the study should be apparently healthy subjects (women and men) with normal body weight. Certain effects related to the structure of the different products on glycemic and insulinemic responses, subjective appetite ratings and other parameters will be examined.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • normal exercise and dietary habbits
  • weight stable for at least 3 months before enrollment

Exclusion criteria

  • pregnancy and lactation
  • diabetes
  • chronic medical illness
  • regular intense exercise (>5 hrs/week)
  • alcohol consumption >2 drinks/day

Treatment and study plan

Finely milled whole wheat-legume bread

Other

The intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight.

Less processed whole wheat-legume bread

Other

The intervention examines the effect of less processed whole wheat-legume bread in subjects with normal body weight.

Less processed whole wheat bread

Other

The intervention examines the effect of less processed whole wheat bread in subjects with normal body weight.

white wheat bread

Other

The intervention examines the reference food product in subjects with normal body weight.

Primary outcomes

  1. Change in glucose incremental area under the curve (iAUC) after consumption of the breads compared to the iAUC after consumption of the reference food.

    Time frame: Time points: 0 (before food consumption), 30, 45, 60, 90,120,180 minutes postprandially (4 times in total).

    Blood glucose concentration will be measured for each participant before and after the test foods, with blood samples being collected at specific time points: 0 (before food consumption), 30, 45, 60, 90, 120, 180 minutes postprandially for each food.

Secondary outcomes

  1. Subjective appetite ratings

    Time frame: Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially (4 times in total).

    Subjective evaluation of hunger, satiety, and desire to eat with Visual Analogue Scales, before the consumption and 30, 60, 90, 120, 180 minutes after (0-100 mm with 0 indicating no hunger or perceived ability to consume food/no satiety or no fullness). Difference in perception of these parameters will be measured and compared between the experimental condition and the control condition.

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

Effects of Less-processed Whole Grain Bread Products (Wheat and Fortified With Legumes) on Postprandial Glucose and Subsequent Metabolic Responses.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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